Recall Z-1120-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338
| Date | Feb 7, 2025 (initiated Jan 8, 2025) |
| Status | Open, Classified |
| Reason | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation. |
| Root cause | Labeling design |
| Action | On January 8, 2025, the firm notified customers through an "Urgent Medical Device Correction" letter sent via email and mailed notices. In addition to explaining software issues affecting the device (covered in RES 96055), the letter also provided customers with a list of mitigations that address device downtime as a result of power failure, network failure, or hardware failure. The firm will be updating product labeling and product guides to further strengthen recommendations. On September 25, 2025, additional correction notices were distributed identifying additional affected devices. If |
| Quantity | 193067 |
| Distribution | Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.